Boehringer Ingelheim, manufacturer of the popular anticoagulant drug Pradaxa, enrolled the first patient in its RE-CCOVERY DVT/PE global observational study.

This new Pradaxa study is set to eventually include 14,000 patients worldwide to collect data on the risk reduction and management of deep vein thrombosis (DVT) and pulmonary embolism (PE) in Pradaxa users.

What is Pradaxa?

Pradaxa (dabigatran) was the first of the new generation oral anticoagulant drugs to hit the market and has been on the market for more than seven years. Pradaxa works by blocking thrombin, the primary enzyme responsible for clot formation.

Pradaxa has been approved by the FDA to prevent stroke and systemic embolism (blood clots) in patients suffering from atrial fibrillation, an abnormal heart rhythm. It has also been approved for preventing blood clots in patients undergoing total hip replacement surgery or total knee replacement surgery as well as for the treatment and prevention of recurrent DVT and PE in adult patients.

New Pradaxa Study Assesses DVT and PE Patients

The new RE-COVERY DVT/PE Pradaxa study was designed to assess how patients suffering from DVT and PE are actually treated in real-world clinical practice and also seeks to add more real-world data regarding the efficacy and safety of the drug compared to warfarin, its predecessor.

For the Pradaxa study, patients will be divided into two groups: Those who receive Pradaxa at 110 mg or 150 mg twice daily and those who are taking warfarin.

Patients in the Pradaxa study will be followed for a year. Special focus will be placed on patients’ personal characteristics, their patterns of treatments, instances of bleeding side effects and recurrent symptomatic deep vein thrombosis and pulmonary embolism.

In a Boehringer press release, Samuel Goldhaber, M.D., a professor of medicine at Harvard and chair of the RE-COVERY DVT/PE Steering committee said, “Large pivotal randomized trials have revolutionized our strategies to manage and reduce the risk of deep vein thrombosis and pulmonary embolism. However, it remains uncertain how the results of these trials impact everyday clinical practice in the real world. We are launching RE-COVERY DVT/PE, an exciting new global prospective observational cohort study, to learn more about DVT and PE patient treatments and outcomes.”

Pradaxa Side Effects

Because Pradaxa works to disrupt the body’s normal clotting mechanisms, clotting is unable to occur while patients are taking the drug. In some circumstances, this proved to be dangerous, and even fatal for some. With the increased bleeding risk, some patients experienced severe gastrointestinal bleeding or brain bleeding with no way to stop the bleeding events.

With warfarin, the precursor anticoagulant that was used before Pradaxa was developed, even though the medication was cumbersome, there was an antidote to use to intervene in bleeding events. Fresh frozen plasma and intravenous vitamin K were used to reverse the anticoagulant effects of the drug.

Until just last September, Pradaxa had no reversal agent or antidote to reverse bleeding in patients, so many patients experienced uncontrolled bleeding that led to damage. For several years, patients who were taking Pradaxa had no way to stop the internal bleeding when it started, other than to wait for the medication to leave the system while the hospital staff tried to keep the patient stable.

Pradaxa Lawsuit Information

Because of the lack of Pradaxa antidote, many patients and their loved ones filed lawsuits against Boehringer Ingelheim alleging the drug was unsafe. In 2014, Boehringer settled the over 4,000 lawsuits pending at that time. Each patient received an average of $160,000 as part of the Pradaxa settlement.

If you or a loved one has suffered from internal bleeding following the use of Pradaxa, you may be entitled to receive legal compensation. A Pradaxa attorney can review your case at no charge and can assist you in determining if filing a lawsuit is right for you.